Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-7756/2a |
Trade Name | Dose Form | Strength | Identifier |
Arrow - Bendrofluazide 2.5 | Tablet | 2.5 mg | |
Sponsor | Application date | Registration situation | Classification |
Teva Pharma (New Zealand) Limited P O Box 128 244 Remuera Auckland 1541 | 3/6/2009 | Consent given Approval date: 10/12/2009 | Prescription |
Reference product: Neo Naclex Tablet 2.5 mg |
Composition
Component | Ingredient | Manufacturer |
tablet | Active | |
Bendroflumethiazide 2.5mg | Ipca Laboratories Limited Sejavta District Ratlam Madhya Pradesh 457 002 INDIA | |
Unichem Laboratories Ltd Plot No. 99, MIDC Area Dhatav-Roha Dist: Raigad 402 116 INDIA | ||
Dipharma Francis Srl Via Origgio 23 Caronno Pertusella Varese 21042 ITALY | ||
Excipient | ||
Lactose | ||
Purified talc | ||
Starch | ||
Stearic acid |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
Manufacture of Final Dose Form | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
Packing | Ipca Laboratories Limited Plot No 255/1 Athal Silvassa Dadra and Nagar Haveli (U T) 396 230 INDIA |
NZ Site of Product Release | Teva Pharma (New Zealand) Limited Level 14, 41 Shortland Street Auckland 1010 |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVD/PVDC, | 14 tablets | 24 months from date of manufacture stored at or below 25°C |
Blister pack, PVD/PVDC, | 28 tablets | 24 months from date of manufacture stored at or below 25°C |
Bottle, plastic, HDPE, | 500 tablets | 24 months from date of manufacture stored at or below 25°C |
Bottle, plastic, HDPE, | 1000 tablets | 24 months from date of manufacture stored at or below 25°C |
Indications
Bendrofluazide is indicated in the treatment of oedema associated with conditions such as: congestive heart failure, nephrotic syndrome and cirrhosis of the liver.
Bendrofluazide is also indicated in the treatment of essential hypertension where it may be used as the sole antihypertensive agent, or as an adjunct to other medicines whose action it potentiates.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
24/9/2021 | Changed Medicine Notification | Indications/dosage - Grade 4; Data sheet - miscellaneous changes; Administrative fee (CMN) | Granted 12/11/2021 | 28/9/2021 | |
3/6/2009 | New Intermediate-risk Medicine Application | Additional name - Grade 1; Additional strength - Grade 1 | Granted 10/12/2009 | 3/6/2009 |